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Quality Control Validation Scientist

Merck Group
St. Louis, United Statesfull_timeVerifiedPosted 7 Jul 2024

About the role

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

 

As a Quality Control Validation Scientist, your primary responsibility will revolve around conducting analytical method qualifications, transfers, and validations to facilitate the testing of samples for raw materials, intermediates, stability, and finished goods, all in strict adherence to ICH / cGMP guidelines and regulations.

 

  • Actively collaborate with multi-functional teams to document precise method-specific operating procedures tailored to each assigned method.
  • Drafting and executing protocols and conclusive reports to qualify, transfer, or validate testing procedures.
  • Adhering to good documentation practices and ensuring compliance with the designated method.
  • Take the lead in technical troubleshooting and process improvements to efficiently manage project milestones for both internal and external clients, ultimately guaranteeing exceptional quality and timely project success.

 

Physical Attributes:

 

  • Wear personal protective equipment such as respirator or chemical protective clothing for extended durations.
  • Lift and push up to 40 pounds unassisted.

 

 

Who You Are:

 

Minimum Qualifications:

 

  • Bachelor's Degree in Chemistry, Biochemistry, Biology, or other life science field.
  • 3+ years of GMP experience in pharmaceutical, biopharmaceutical or chemical industry.
  • 2+ years of experience validating analytical methods or cleaning methods or 5+ years of experience in GMP analytical testing of proteins or other biologics.

 

Preferred Qualifications:

 

  • Master’s Degree in Chemistry, Biochemistry, Biology, or other life science field.
  • Previous experience performing, reviewing, and/or troubleshooting analytical methods to support bio-organics, protein, or bio-conjugate products. These techniques may include UV, SolVPE, HPLC, GC, iCE, CGE and wet chemistry techniques.
  • Strong technical writing, root cause analysis and scientific reasoning.
  • Effective communication in cross-functional teams and working with external customers.

 

RSREMD

 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our dive

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Company

Merck Group

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